The effects of telerehabilitation in adults with complex biventricular congenital heart conditions: protocol for a multi-centre, randomised controlled trial—CH-FIT

Background Accumulated evidence suggests that exercise training exerts beneficial effects on people with congenital heart conditions. These findings are predominantly derived from small, single-centre exercise trials conducted in outpatient rehabilitation facilities. In recent years, the delivery of exercise interventions remotely has increased through digital communications technology (telerehabilitation). However, very little research to date has been conducted into the efficacy of telerehabilitation in people with a congenital heart condition. Aims To evaluate the effects of a telehealth-delivered exercise intervention in people with a history of a surgical biventricular repair due to a congenital heart condition. Methods One hundred eligible adolescent (≥ 16 years) and adult participants living with a complex biventricular congenital heart condition will be recruited from four Australian sites and randomised to either (1) a 16-week telehealth-delivered combined (aerobic and resistance) exercise training programme of moderate-to-vigorous intensity or (2) usual care (control group), in a 1:1 allocation, with an 8-month follow-up. Outcomes of interest The primary outcome will be the change in aerobic capacity expressed as peak oxygen uptake (VO2peak). Secondary outcomes will include changes in vascular function, muscle oxygenation, metabolic profile, body composition and musculoskeletal fitness, neurohormonal activation, neurocognitive function, physical activity levels, dietary and nutritional status, and quality of life. Outcomes will be assessed at baseline, 16 weeks, and 12 months (to determine longer-term maintenance potential). Discussion If found to be efficacious, telerehabilitation may be an alternative option for delivering exercise, improving health outcomes, and increasing accessibility to exercise programmes. Efficacy data is required to quantify the clinical significance of this delivery mode of exercise. Trial registration ACTRN12622000050752 Trial registration date: 17 January 2022 Trial registration URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=382635&showOriginal=true&isReview=true Trial registry name: Australian and New Zealand Clinical Trials Registry Supplementary Information The online version contains supplementary material available at 10.1186/s13063-024-08019-7.


Cardiovascular
Other cardiovascular diseases Physical Medicine / Rehabilitation Other physical medicine / rehabilitation

Intervention/exposure
Study type

Description of intervention(s) / exposure
Eligible participants will be randomised to either a supervised (or partially) physical activity and exercise program of moderate to vigorous intensity, followed by an 8-month maintenance period; or usual care (control) group.Throughout the intervention period, participants in the intervention groups will also receive education to promote a healthy lifestyle.In the intervention groups, a 5-10 minute warm-up and cool down will be performed before and after each session.Adherence will be monitored by recording session attendance.Sessions in the 4-month supervised (or partially supervised) phase will be delivered by exercise professionals (e.g., exercise physiologists, physiotherapists) in small groups.
Adolescents and adults with biventricular congenital heart disease will be randomly allocated to a telehealth exercise training group or usual care group; Fontan participants may also be allocated to a traditional exercise training group.Children will be randomly allocated to a physical activity and exercise training group or usual care group.
The exercise intervention in the traditional exercise group will involve supervised aerobic (e.g., cycling) and resistance exercise (e.g., leg press, chest press) training 3 times a week for 4 months.Sessions will be ~60-75 minutes and supervised by exercise professionals.Aerobic exercise will commence at 40%-50% of heart rate reserve (HRR) and progress to 70%-80% HRR, as tolerated.The resistance exercise component will involve 3 sets of 8-12 repetitions at 60% of one-repetition maximum (1RM) and progressed to 70% 1RM.
The telehealth exercise training group will perform supervised resistance exercise 3 times a week for 4-months on Zoom.Each supervised resistance training session will be ~45-60 minutes in duration.
Participants will perform 3 sets of 8-12 repetitions of various exercises using bodyweight or a Gymstick.
Resistance exercise intensity and progression will be monitored by rating of perceived exertion on the OMNI scale.Participants in the telehealth exercise training group will also be asked to perform 20 minutes of aerobic exercise training (e.g., walking) independently 3 times a week for 4-months.Aerobic exercise intensity will be monitored by HRR and is consistent with the traditional exercise training group.
Children allocated to the intervention group will participate in a 4-month supervised physical activity and exercise training program.Participants will attend a community or fitness facility once a week for ~90 minutes to perform an interval exercise circuit, practice foundational movement skills and engage in physically active games.The average target exercise intensity for the exercise circuit will be 40%-50% HRR initially and will progress to 70%-80% HRR, as tolerated.In addition, children will be provided with tasks to complete at home (e.g., calf raises) that supplements the physical activity program and promotes a healthy lifestyle.
During the 8-month maintenance phase, adolescent and adult participants allocated in the exercise intervention groups will be encouraged to continue exercise training independently at least 2 times a week.Children will be encouraged to be physically active and join sports clubs.Follow-up phone calls will be conducted monthly to facilitate ongoing physical activity participation.
Participants in the usual care group will continue with routine clinical care and attend testing visits at baseline, 4-months, and 12-months.

Rehabilitation
Comparator / control treatment Participants allocated to the control group will continue with routine clinical care as directed by their medical team.

Outcomes Primary outcome [1]
Change in peak oxygen uptake assessed by cardiopulmonary exercise testing

Timepoint [1]
Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).

Secondary outcome [1]
Changes in cardiopulmonary exercise testing measures analysed by a metabolic cart

Timepoint [1]
Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).

Secondary outcome [2]
Changes in respiratory muscle function (only in Fontan participants) assessed by pulmonary function testing instruments (via maximal static inspiratory and expiratory pressures).

Timepoint [2]
Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).

Secondary outcome [3]
Changes in body composition measured by dual-energy x-ray absorptiometry

Timepoint [3]
Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).

Secondary outcome [4]
Changes in liver stiffness measure by liver elastography (only in Fontan participants)

Timepoint [4]
Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).

Secondary outcome [5]
Changes in neurocognitive function assessed Cogstate

Timepoint [5]
Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).

Secondary outcome [6]
Changes in near-infrared spectroscopy measures including deoxy hemoglobin, oxyhemoglobin, and skeletal muscle oxidative capacity (composite outcome).

Timepoint [6]
Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).

Secondary outcome [7]
Changes in physical activity levels measured by accelerometers

Timepoint [7]
Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).

Secondary outcome [8]
Changes in vascular function assessed by flow-mediated dilation (only in Fontan participants)

Timepoint [8]
Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).

Timepoint [9]
Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).

Secondary outcome [10]
Changes in cardiac function assessed by transthoracic echocardiography (only in Fontan participants)

Timepoint [10]
Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).

Secondary outcome [11]
Changes in cardiac function assessed by resting and exercise cardiac MRI (only in Fontan participants)

Timepoint [11]
Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).

Secondary outcome [12]
Changes in health-related quality of life assessed by PedsQL

Timepoint [12]
Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).

Secondary outcome [13]
Changes in health economics and patient costs assessed by data-linkage to medicare, CHU-9D and EQ5D.

Timepoint [13]
Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).

Secondary outcome [14]
Changes lung function (only in Fontan participants) assessed by pulmonary function testing instruments (via spirometry and body plethysmography).

Timepoint [14]
Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).

Secondary outcome [15]
Changes in handgrip strength (in children, adolescents, and adults) assessed by a hand-grip dynamometer.

Timepoint [15]
Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).

Secondary outcome [16]
Changes in one-repetition maximum assessed by one-repetition maximum testing (in adolescents and adults).

Timepoint [16]
Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).

Secondary outcome [17]
Changes in and muscular endurance assessed by musculoskeletal endurance testing (in adolescents and adults).

Timepoint [17]
Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).

Secondary outcome [18]
Changes in the number of push-ups performed (in children).

Timepoint [18]
Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).

Secondary outcome [19]
Changes in standing long jump distance (in children).

Timepoint [19]
Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).

Secondary outcome [20]
Changes in dietary and nutrition intake assessed by the ASA24.

Timepoint [20]
Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).

Secondary outcome [21]
Changes in malnutrition assessed by the SGA or SGNA

Timepoint [21]
Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).

Secondary outcome [22]
Changes in energy expenditure assessed by and indirect calorimetry.

Timepoint [22]
Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).

Secondary outcome [23]
Changes in gastrointestinal symptoms assessed by the GSRS.

Timepoint [23]
Baseline, 4 months (primary timepoint) and 12 months after the usual care period or starting the exercise program (i.e., 4-months and 12-months from baseline testing for each group).Royal Prince Alfred Hospital -Camperdown

Recruitment hospital [2]
The Prince Charles Hospital -Chermside

Recruitment hospital [4]
The Royal Childrens Hospital -Parkville

Recruitment hospital [8]
Royal NationalHealth & Medical Research Council, the Medical Research Future Fund (MRFF)